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Hyderabad, <keyword id="138856" type="DOMAIN" weightage="20" keywordseo="Aurobindo-Pharma-Ltd">Aurobindo Pharma Ltd</keyword> and Covaxx, a US-based company, have entered into an <keyword id="10489747" type="UNKNOWN" weightage="20" keywordseo="exclusive-license-agreement">exclusive license agreement</keyword> to develop, commercialise and manufacture UB-612, the first Multitope Peptide-based vaccine to fight COVID-19, for <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> and UNICEF. According to a release issued by the city-based drug maker, Covaxx is currently conducting a Phase 1 clinical trial for the vaccine candidate. Managing Director of <keyword id="70473" type="DOMAIN" weightage="20" keywordseo="Aurobindo-Pharma">Aurobindo Pharma</keyword> Ltd, N Govindarajan, said, "We are proud to partner with Covaxx in developing the first-ever synthetic peptide-based vaccine to combat the <keyword id="8902449" type="UNKNOWN" weightage="20" keywordseo="covid-19-pandemic">COVID-19 pandemic</keyword>. This vaccine has immense potential in eliminating shedding, and hence containing, the spread of the pandemic." Under the signed agreement, Aurobindo Pharma has obtained the exclusive rights to develop, manufacture and sell Covaxxs UB-612 vaccine in India and to UNICEF, as well as non-exclusive rights in other select emerging and developing markets, it said. Aurobindo Pharma and Covaxx are partnering on clinical development, manufacturing and marketing of the vaccine candidate. Aurobindo will manufacture the finished doses at its facilities in Hyderabad. It has the capacity of manufacturing 220 million doses in multi-dose presentation and is building additional facilities to have a total capacity of nearly 480 million doses by June 2021. Mei Mei Hu, co-founder and CEO of Covaxx said his company is committed to providing an equitable distribution of UB-612 by prioritizing emerging markets where there is the unmet need. "During this global health crisis response, we must establish partners with the strongest capabilities, like Aurobindo, to prioritize the development and the delivery of our vaccine. As one of the leading industry players with a strong track record of execution and investment in vaccines, Aurobindo Pharma is the ideal partner to advance UB-612 in India and other emerging nations and to support our mission of democratizing health worldwide," Hu said. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-mrs-bectors-ril-bharti-airtel-vodafone-idea-ilfs-interglobe-aviation-future-group-deepak-nitrite-jubilant-foodworks-and-others/articleshow/79933826.cms">Top stocks to watch – Mrs Bectors, RIL, Bharti Airtel, Vodafone Idea, IL&amp;FS, InterGlobe Aviation, Future Group, Deepak Nitrite, Jubilant FoodWorks, and others</a> <a href="https://www.businessinsider.in/thelife/personalities/news/from-taking-on-yahoo-to-being-tamed-by-chinas-communist-party-its-been-a-roller-coaster-decade-for-jack-ma/slidelist/79935613.cms">From taking on Yahoo to being tamed by China’s Communist Party— it’s been a roller coaster decade for Jack Ma</a> <a href="https://www.businessinsider.in/careers/news/ey-is-looking-to-hire-9000-techies-in-2021-to-boost-its-digital-services/articleshow/79936576.cms">EY is looking to hire 9,000 techies in 2021 to boost its digital services</a>

Aurobindo Pharma join hands with US-based company Covaxx to develop COVID-19 vaccine for India

HDFC Bank, InterGlobe Aviation, Mahindra & Mahindra and other stocks to watch out for on May 31

ONGC, SpiceJet, Aurobindo Pharma and other stocks to track as Sensex looks set to continue rebound

<ul><li>The Nifty Pharma index gained 2.82% during the early trading hour.</li><li>These were the top gainers in the Nifty Pharma pack.</li><li><a href="https://www.businessinsider.in/">Check out the latest news and updates on Business Insider.</a> </li></ul>The Nifty Pharma index gained 2.82% during the early trading hour. Pharma stocks have been on a roll over the past few days. Nifty Pharma index was trading 382.50 points higher, while the Nifty 50 index was up 44 points at 9:30 am. These were the top gainers in the Nifty Pharma pack: Lupin gained 7%, and Cipla was up 5% The shares of Lupin Limited gained 7%, and Cipla was trading 5% higher during the trade on September 18. The jump in the shares of the pharma companies came after its Irish-peer Perrigo voluntarily recalled albuterol inhalation. This development bodes well for Lupin and Cipla. Cipla launched gProventil in April this year, and Lupin’s gProAir is expected to be launched this month. Dr Reddy’s Laboratories gains 4% Dr.Reddy’s Laboratories was the third-largest gainer in the Nifty pharma pack, trading almost 4% higher. The company has announced a settlement of litigation with a unit of Bristol Myers Squibb related to patents for Revlimid (lenalidomide) capsules, used to treat various kinds of cancer. “We are pleased with the settlement agreement, and look forward to bringing a generic version of lenalidomide to market soon subject to regulatory approval for the benefit of patients,” Dr Reddy’s Laboratories North America Generics CEO Marc Kikuchi said. Other pharma stocks surge in trade as well Other pharma were also trading higher fueled by the rally in the pharma sector. Sun Pharma, Divi’s Laboratories, Aurobindo Pharma and Torrent Pharmaceuticals are all up over 2%. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-dr-reddys-laboratories-hdfc-bank-tvs-motor-vedanta-irctc-lt-bharat-forge-hal-and-more/articleshow/78179393.cms" data-type="tilCustomLink">Top stocks to watch— Dr Reddy's Laboratories, HDFC Bank, TVS Motor, Vedanta, IRCTC, L&amp;T, Bharat Forge, HAL, and more</a> <a href="https://www.businessinsider.in/sports/news/dailyhunt-app-founders-confirm-ipl-2020-associate-sponsorship/articleshow/78169667.cms" data-type="tilCustomLink">EXCLUSIVE: Dailyhunt founders confirm IPL 2020 associate sponsorship — promise new release for Josh ahead of India’s biggest cricket tournament</a>

Top pharma stock movers — Lupin, Cipla, Dr Reddy’s steal the show

<ul><li>The 30-share BSE index was trading 239 points lower, and the broader NSE Nifty was down 0.52% on Thursday at 10:00 am. </li><li>Here’s a list of the top losers and gainers in the Nifty pack. </li><li>These are the top stocks that are buzzing in trade today.</li><li><a href="https://www.businessinsider.in/">Check out the latest news and updates on Business Insider.</a> </li></ul>The Indian equity benchmark indexes started on a weak note on Thursday, tracking losses in financial stocks ahead of Finance Minister Nirmala Sitharaman’s press conference. The 30-share BSE index was trading 239 points lower, and the broader NSE Nifty was down 0.52% on Thursday at 10:00 am. Here’s a list of the top losers and gainers in the Nifty pack. <table style="border-width: initial; border-style: none;"></colgroup><tbody><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Top Nifty Gainers </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Top Nifty Losers </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Hindalco </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Coal India </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">M&amp;M </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">HDFC </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Shree Chem </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">IndusInd Bank </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipla </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Kotak Mahindra Bank </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sun Pharma </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Axis Bank </td></tr></tbody></table>*as of November 12, 10:06 am These are the top stocks in news today. Indiabulls Housing Finance leaps 6% The shares of Indiabulls Housing Finance gained over 6% after it reported an 18.5% jump to ₹323.20 crore in its quarter-on-quarter net profit. However, its total income fell 25.9% year-on-year to ₹2,581 crore during the quarter under review. Happiest Minds Tech up over 1% The shares of Ashok Soota backed Happiest Minds Tech gained over a percent after it entered into a strategic partnership with Bengaluru-based lo-Tahoe to provide their clients with effective data discovery and governance solutions. Ashoka Buildcon zooms 6% The shares of Ashoka Buildcon zoomed 6% in a weak market after the highways builder reported a six-fold jump in consolidated profit after tax (PAT) to ₹70.42 crore for the quarter ended September 30. Aurobindo Pharma up over 5% Pharma giant Aurobindo Pharma shares soared over 5% after it reported a 26% increase in consolidated net profit to ₹805.65 crore in the second quarter ended September 30. The company’s consolidated total revenue from operations during the period under review stood at ₹6,483.44 crore as against ₹5,600.47 crore in the corresponding quarter last year. Hindalco Industries trade 3% higher The shares of Hindalco Industries were up 3% after brokerage reiterated a ‘buy’ rating citing a sharp turnaround at Novelis, the American subsidiary of Hindalco. Edelweiss Securities has set a target price of ₹250, and IIFL has set a target price of ₹212. Coal India falls over 3% The shares of state-run Coal India fell over 3% after it reported a 16% fall in its consolidated net profit to ₹2,951 crore in the second quarter ending September 30. Although, the company’s revenue from sales was at ₹19,484 crore during the quarter under review as against ₹18,986 crore in the year-ago period. SEE ALSO: <a href="https://www.businessinsider.in/policy/economy/news/indian-government-approves-the-pli-scheme-for-10-sectors/articleshow/79172901.cms" data-type="tilCustomLink">Indian government approves the Production Linked Incentive scheme for 10 sectors worth ₹2 lakh crore</a> <a href="https://www.businessinsider.in/business/corporates/news/spicejet-shrink-its-losses-to-112-59-crore-in-the-second-quarter-ended-september-30/articleshow/79172678.cms" data-type="tilCustomLink">Spicejet is losing one rupee where it was losing four thanks to cheaper fuel and cut in rentals</a>

Top stock movers — Hindalco, Indiabulls Housing, Happiest Minds Tech, Ashoka Buildcon, Aurobindo Pharma and others

New Delhi, Jan 30 () Aurobindo Pharma on Friday said its joint venture firm Eugia Pharma Specialities has received approval from the US health regulator to market Methotrexate tablets, used to treat various types of cancer, in the American market.
 Eugia Pharma, in which the company holds a stake, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Methotrexate tablets (2.5 mg), Aurobindo Pharma said in a regulatory filing.
 The company's product is the generic version of Dava Pharmaceuticals' Rheumatrex tablets, it added.
 "The product will be launched in March 2020," the Hyderabad-based firm said.
 As per IQVIA data, the product had an estimated market size of USD 98 million (about Rs 695 crore) for the twelve months ended December 2019.
 Methotrexate tablets are indicated in the treatment of gestational choriocarcinoma. They are also used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer.
 The drug is also used in the treatment of psoriasis and rheumatoid arthritis.
 "This is the ninth abbreviated new drug application (ANDA) to be approved out of Eugia's formulation facility in Hyderabad," Aurobindo Pharma said.
 The drug major now has a total of 420 ANDA approvals from the USFDA.
 Shares of Aurobindo Pharma on Friday ended 0.22 per cent higher at Rs 481.35 apiece on the BSE. MSS 
RVK

Eugia Pharma gets USFDA nod for generic drug: Aurobindo Pharma

<ul><li>The benchmark index Sensex was trading 0.32% higher at 38,493.24</li><li>The NSE Nifty was up 0.41% at 11,354.40. </li><li>These are the top stocks that are buzzing the D-street today.</li><li><a href="https://www.businessinsider.in/">Check out the latest news and updates on Business Insider.</a> </li></ul>Domestic equity benchmark Sensex jumped over 100 points in early trade on Thursday led by gains in index majors TCS, Infosys and HUL amid firm cues from global peers and sustained foreign fund inflow. The benchmark index Sensex was trading 0.32% higher at 38,493.24; while NSE Nifty was up 0.41% at 11,354.40. These are the top stocks that are buzzing the D-street today: IndiGo’s parent Interglobe Aviation shares rallied nearly 8% during the morning tarde <keyword id="678811" type="COMPANY" weightage="20" keywordseo="Westbridge-Capital">Westbridge Capital</keyword>, a private equity firm bought 1.41% stake in India's largest domestic airline IndiGo for ₹559 crore through an open market transaction. Strides Pharma trading nearly 1% higher Strides Pharma promoters announced the acquisition of the 3.7% stake owned by Sequent Scientific. The acquisition of stake will be at ₹475 per share, and the transaction is expected to be completed in the next coming months. Ashok Leyland nose dived over 2% Hinduja Group flagship firm Ashok Leyland shares were trading nearly 2% lower after the company reported a consolidated net loss of ₹388.82 crore for the first quarter ended June 30. The company’s revenue from operations in April-June 2020 significantly declined to ₹1,486.04 crore as compared with ₹6,588.23 crore in the year-ago period. <keyword id="80296" type="COMPANY" weightage="20" keywordseo="Eicher-Motors">Eicher Motors</keyword> trading more than a percent lower Eicher Motors is slated to report its first quarterly earnings today. The share price was trading 1.07% lower during the morning trade as analysts expect the street is expecting a 63% revenue dip and over 90% fall in its profit in the first-quarter earnings. <keyword id="2797147" type="PERSON" weightage="20" keywordseo="Aurobindo-Pharma-shares">Aurobindo Pharma shares</keyword> decline 2.95% Despite posting a 22.8% rise in its net profit for the quarter ended on June 30, the shares of drugmaker Aurobindo Pharma declined nearly 3% in the early hours of trading. TCS, HCL Wipro and other tech shares rally during the morning trade IT stocks rallied after the Donald Trump administration announced certain exemptions in the H-1B and L-1 travel ban for those continuing employment with the same employer. All three major Tech companies’ shares were trading above 2% higher than the previous close. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-today-britannia-hero-motocorp-ashok-leyland-mm-financial-indiabulls-housing-and-more/articleshow/77516263.cms" data-type="tilCustomLink">Top stocks to watch today— Britannia, Hero MotoCorp, Ashok Leyland, M&amp;M Financial, Indiabulls Housing and more</a> <a href="https://www.businessinsider.in/tech/news/it-only-takes-50-tweets-to-find-a-troll-on-twitter/articleshow/77512151.cms" data-type="tilCustomLink">It only takes 50 tweets to find a troll on Twitter</a>

Top stock movers on Dalal Street today — TCS, HCL, Wipro, Ashok Leyland, IndiGo and more

New Delhi, Jan 2 () Aurobindo Pharma USA Inc said it is voluntarily recalling Mirtazapine tablets, used for the treatment of major depressive disorder, in the US market.
 The product is being recalled due to a label error on declared strength. Bottles labelled as Mirtazapine 7.5 mg may contain 15 mg tablets, as per the company's announcement posted on the website of the United States Food and Drug Administration (USFDA).
 The company is recalling lot number 03119002A3 of tablets to the consumer level, it added. 
 "Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more," the announcement said.
 Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults, it added.
 The company said it is notifying its distributors by letter and is arranging for return of all of the recalled product. Distributors/retailers that have product which is being recalled should return the bottle(s) to place of purchase.
 The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products, it added.
 "Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," the announcement said.
 Mirtazapine tablets are indicated for the treatment of major depressive disorder and are packaged in 500 count bottle, it added. AKT MR

Aurobindo Pharma Inc recalls Mirtazapine tablets in US

<ul><li>A US court has ordered generic drug makers to stop selling a copy of Gilenya in US.</li><li>The annual sales of Gilenya, a drug used to treat multiple sclerosis, was about $3.3 billion in 2018.</li><li>The judge pegged the cumulative loss of opportunity on generic drug makers at $50 million.</li></ul> A US court has ordered generic drug makers including Mylan, Dr Reddy's Laboratories, Aurobindo Pharma, and Torrent Pharma to stop selling a copy of Gilenya, for which Novartis holds the patent. The annual sales of Gilenya, a drug used to treat multiple sclerosis, was about $3.3 billion in 2018 and the judge pegged the cumulative loss of opportunity on generic drug makers at $50 million. Novartis has sought to extend its patent on Gilenya beyond 2027, and the deadline to appeal for the extension ends this year. The patent case is still under trial. Double blow The court verdict has come a day after an Indian broking house, India Infoline (IIFL) downgraded Dr Reddy's by a notch. "The company’s market share uptake in Suboxone has been slow, and the key product filings of Nuvaring and Copaxone have also seen some delays," the report said. It has been a double whammy for Aurobindo Pharma too. The US Food and Drug Administration (USFDA) has issued a warning letter for one of the company's unit in Srikakulam in Andhra Pradesh. The unit, which manufactures active pharmaceutical ingredients, was inspected by the American drug regulator in February 2019 after the 'sartan' recall. "Our analysis of 34 WLs and interactions with the company suggest that the facility will be allowed to continue supplying existing molecules. However, future approvals will be withheld until the issues are resolved. There are 12 ANDAs (generic drug applications), including one injectable, pending from Unit 11, of which seven approvals were expected in FY20 and five in FY21. While a majority of these filings are „me too‟ products, there are a few that represent an $10mn+ opportunity annually," a report from SBI Cap Securities said, adding that if the warning escalated to a import ban into the US from the said facility, it could lead to 15% to 20% fall in earnings. SEE ALSO: <a href="https://www.businessinsider.in/abbvies-63-billion-mega-deal-for-botox-maker-allergan-is-the-pharma-industrys-latest-bet-that-bigger-is-better-but-the-deal-is-already-facing-big-questions-/articleshow/69945829.cms" data-type="tilCustomLink" target="_blank">AbbVie's $63 billion mega-deal for Botox-maker Allergan is the pharma industry's latest bet that bigger is better. But the deal is already facing big questions.</a> <a href="https://www.businessinsider.in/donald-trump-on-generic-drugs-indian-pharma-and-katherine-ebans-new-book-with-dinesh-thakur/articleshow/69407566.cms" data-type="tilCustomLink" target="_blank">The man who brought Ranbaxy to its knees is pushing for ‘Made in India’ tag on drugs sold in US</a> <a href="https://www.businessinsider.in/us-generic-drugs-risk-rises-for-indian-pharma-after-new-book-launch/articleshow/69332570.cms?utm_source=contentofinterest&amp;utm_medium=text&amp;utm_campaign=cppst" data-type="tilCustomLink" target="_blank">One chart from a big pharma CEO reveals how drug pricing in the US really works</a>

Mylan, Dr Reddy's, Aurobindo, and Torrent Pharma can't sell generic Gilenya that is patented by Novartis

New Delhi, Feb 21 () Drug firm Aurobindo Pharma on Friday said the US health regulator has revoked the voluntary action initiated (VAI) status for its Unit-IV facility in Hyderabad. The company has received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our Unit IV, from November 4 to 13, 2019 is "still open and under review, by way of rescindment of 90-day VAl letter that was issued by them on February 18, 2020," Aurobindo Pharma said in a filing to BSE. The USFDA had in earlier in November 2019 issued a Form 483 with 14 observations after the inspection of Aurobindo Pharma's Unit-IV, a general injectable formulation manufacturing facility. AKT AKT MRMR

USFDA rescinds VAI status for Aurobindo Pharma's Hyderabad unit

<ul><li>The American drug regulator approved 953 new generic drugs between October 2018 and June 2019.</li><li>This is the highest number of approvals in the first nine months of any fiscal year from the USFDA, according to a report.</li><li>While the new approvals will put pressure on existing drugs to be cheaper, the silver lining for companies is that new applications have slowed down.</li></ul>The United States Food and Drug Administration (USFDA) has generously doled out approvals for new drugs and that is likely to show in the profits of Indian drug makers like <keyword id="44642" type="CITY" weightage="20" keywordseo="Sun-Pharma">Sun Pharma</keyword>, <keyword id="46698" type="CITY" weightage="20" keywordseo="Lupin">Lupin</keyword>, <keyword id="7875008" type="UNKNOWN" weightage="20" keywordseo="dr-redddys-laboratories">Dr Redddy's Laboratories</keyword>, and <keyword id="70473" type="COMPANY" weightage="20" keywordseo="Aurobindo-Pharma">Aurobindo Pharma</keyword> when the earnings start tumbling out this month. The American drug regulator approved 953 new generic drugs between October 2018 and June 2019. This is the highest number of approvals in the first nine months of any fiscal year from the USFDA, according to a report from Ashika Institutional Research. Companies have been battling the pricing pressure in US for a while now and the profit squeeze has taken a lot out of stock prices in recent years. On one hand, there is a two-pronged pressure consistently squeezing drug prices-- one from <a href="https://www.businessinsider.in/The-Trump-administration-has-a-little-known-practice-in-the-pharma-industry-in-its-crosshairs/articleshow/64124087.cms" data-type="tilCustomLink" target="_blank">the Donald Trump administration</a> and the other from the <a href="https://www.livemint.com/market/mark-to-market/us-disruption-may-have-singed-indian-pharma-but-it-is-emerging-stronger-1557253325315.html" data-type="tilCustomLink" target="_blank">rising competition</a> in generic drugs. Over the past three years, sales per marketed product (in US) have declined by about 30%, according to a report by global investment bank Nomura in March 2019. At the same time, <a href="https://www.businessinsider.in/seven-indian-pharma-companies-are-being-dragged-into-a-us-lawsuit-over-high-drug-prices/articleshow/69318841.cms" data-type="tilCustomLink" target="_blank">seven Indian companies</a> -- Sun Pharma, Dr Reddy’s Laboratories, Glenmark Pharma, Lupin, Wockhardt, Zydus Pharma and Aurobindo Pharma-- are facing a lawsuit in over 40 American states for acting like a cartel to keep drug prices up. "However, given intensifying competition due to faster generic approvals and regulatory headwinds, the litigation raises the risk associated with the US generics business for companies involved in the litigation," a report from an Indian brokerage, Motilal Oswal, on May 14 said. At rock bottom While the new approvals will put pressure on existing drugs to be cheaper, the silver lining for companies is that new applications have slowed down. "We are seeing mild slowdown with total 696 ANDAs submitted in the first 9 months of the fiscal year, down 8% (YoY). As major generic companies continue to exit unattractive products, ANDA (generic drug) submissions are seeing this slowdown," the report said. In terms of profit margins, Indian drug makers, who rely a lot on the US market for their revenue, have little to lose and a lot to gain from the low base of previous years. According to estimates from Karvy, the margin for most companies is expected to have widened significantly in the three months ended June 2019, compared to the same period a year earlier. <table style="width: 166pt;"> </colgroup> <tbody><tr> <td class="xl66" style="height:15.0pt;width:82pt">Company</td> <td class="xl67" style="border-left-width: initial; border-left-style: none; width: 84pt;">Profit Margin</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Lupin</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">+732 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Sun Pharma</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">-253 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Torrent Pharma</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">+118 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Cadila Health</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">-45 basis points</td> </tr> <tr> <td class="xl68" style="height: 15pt; border-top-width: initial; border-top-style: none;">Dr Reddy's Labs</td> <td class="xl69" style="border-top-width: initial; border-top-style: none; border-left-width: initial; border-left-style: none;">+217 basis points</td> </tr> <tr> <td colspan="2" class="xl70" style="border-right:1.0pt solid black; height:15.0pt;width:166pt">Source: Karvy Stock Broking </td> </tr> <tr> <td colspan="2" class="xl72" style="border-right:1.0pt solid black; height:15.75pt">100 basis points make 1%</td> </tr></tbody></table> SEE ALSO: <a href="https://www.businessinsider.in/donald-trump-on-generic-drugs-indian-pharma-and-katherine-ebans-new-book-with-dinesh-thakur/articleshow/69407566.cms" data-type="tilCustomLink" target="_blank">The man who brought Ranbaxy to its knees is pushing for ‘Made in India’ tag on drugs sold in US</a>

USFDA has set a new record in generic drug approvals this year-- but Indian drug makers have a lot to gain and little to lose

New Delhi, Feb 26 () Aurobindo Pharma Ltd on Wednesday said that it has received an establishment inspection report from the US health regulator with Voluntary Action Initiated (VAl) status for its Unit VIII manufacturing facility in Hyderabad. "Further to our intimation dated November 6, 2019 with regard to the USFDA inspection of Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad, we would like to inform that the company has received the Establishment Inspection Report (EIR) with VAl status from the USFDA," the drug firm said in a filing to BSE. According to the US health regulator, a VAI classification "means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action". USFDA issues an EIR to the company when an inspection is satisfactorily closed. Shares of Aurobindo Pharma were trading at Rs 508.50 a piece on BSE, up 0.87 per cent from the previous close. SID DRR

Aurobindo Pharma gets EIR with VAI status from USFDA for Hyderabad facility

New Delhi, Feb 19 () Drug firm Aurobindo Pharma on Wednesday said it has received an establishment inspection report from the US health regulator with voluntary action indicated (VAI) status for its Unit-IV facility in Hyderabad. The United States Food and Drug Administration (USFDA) had in November 2019 issued a Form 483 with 14 observations after the inspection of its Unit-IV, a general injectable formulation manufacturing facility situated at Hyderabad. The regulator had inspected the facility from November 4 to November 13 last year, Aurobindo Pharma said. "The company has received the establishment inspection report (EIR) with VAI status from USFDA," Aurobindo Pharma said in a regulatory filing. According to the US health regulator, a VAI classification "means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action". Shares of Aurobindo Pharma on Wednesday rose 20.40 per cent to close at Rs 602.25 per scrip on the BSE. AKT HRS

Aurobindo Pharma gets EIR with VAI classification from USFDA for Hyderabad unit

New Delhi, Jan 30 () Drug firm Aurobindo Pharma on Thursday reported that the US health regulator has cautioned that its oral solids formulation manufacturing facility may be subject to regulatory actions.
 The company stressed that it will work closely with the US Food and Drug Administration (USFDA) to comprehensively address the issues.
 "Further to our intimations... with regard to the USFDA inspection of Unit VII, an oral solids formulation manufacturing facility of the company, we inform you that the company has received a letter from the USFDA classifying the inspection conducted at the aforesaid facility as official action indicated (OAI)," Aurobindo Pharma Ltd said in a filing to BSE.
 According to USFDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections.
 The company said that it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture.
 The shares of Aurobindo Pharma were trading at Rs 484.50 apiece on BSE, down 4.49 per cent from the previous close. SID ANS
ANS

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